```

[Federal Register Volume 88, Number 160 (Monday, August 21, 2023)]
[Notices]
[Pages 56834-56836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17921]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-23-22FZ; Docket No. CDC-2023-0072]

Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

-----------------------------------------------------------------------

SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled mChoice: Improving PrEP Uptake 
and Adherence among Minority MSM through Tailored Provider Training and 
Adherence Assistance in Two High Priority Settings. The collection is 
part of a research study designed to implement and evaluate the 
effectiveness of an intervention that utilizes evidence-based education 
and support tools to improve preexposure prophylaxis (PrEP) adherence 
among young men who have sex with men (YMSM).

DATES: CDC must receive written comments on or before October 20, 2023.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0072 by either of the following methods:
    [square] Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
    [square] Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS H21-8, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.regulations.gov) or by U.S. mail to the address listed 
above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7118; 
Email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below. The OMB is particularly 
interested in comments that will help:
    1. Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected;
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submissions of responses; and
    5. Assess information collection costs.

Proposed Project

    mChoice: Improving PrEP Uptake and Adherence among Minority MSM 
through Tailored Provider Training and Adherence Assistance in Two High 
Priority Settings--New--National Center for HIV/AIDS, Viral Hepatitis, 
STD, and TB Prevention (NCHHSTP), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    The National Center for HIV/AIDS, Viral Hepatitis, STD and TB 
Prevention is requesting approval for 36 months of data collection 
titled, ``mChoice: Improving PrEP Uptake and Adherence among Minority 
MSM through Tailored Provider Training and Adherence Assistance in Two 
High Priority Settings.'' The purpose of this study is to implement and 
evaluate the effectiveness of a clinic-based intervention that utilizes 
evidence-based education and support tools to improve preexposure 
prophylaxis (PrEP) adherence among young men who have sex with men 
(YMSM). The goals of this research study are to: (1) improve the 
overall PrEP experience of providers and YMSM patients; and (2) 
increase our understanding of provider and patient factors that 
influence the choice of PrEP regimen by MSM in clinical settings. This 
study will be carried out in four clinics in New York, NY (two clinics) 
and Birmingham, AL (two clinics).

[[Page 56835]]

    Aim 1 of the study will enroll 400 YMSM (ages 18-39) who identify 
as male, non-binary, or genderqueer; were assigned male sex at birth; 
are taking or initiating PrEP; own a smartphone; understand and read 
English or Spanish; have a self-reported history of sex with men in the 
past 12-months; and live in the NYC or Birmingham, AL areas. 
Participants may identify as any race or ethnicity, but to ensure a 
diverse sample comprised mainly of racial/ethnic minority participants, 
the study will utilize recruitment controls to enroll at least 50% 
African American/Black and/or Hispanic/Latino participants. Patient 
participants will be recruited to the study through a combination of 
approaches including flyers and social media, referral, in-person 
outreach, and through word of mouth. Rolling enrollment will continue 
until enrollment targets are reached; each Aim 1 participant will be 
followed for 12 months. All participants will receive PrEP clinical 
services congruent with CDC PrEP guidelines. Participants using oral 
PrEP will receive CleverCap, an electronic medication monitoring 
device, that will track and support medication adherence. At the 3-
month study visit, participants using oral PrEP will receive the 
mChoice mobile phone application, an evidence-based intervention that 
supports PrEP use through medication monitoring, study staff 
interaction, and other resources. Aim 1 assessments include: a baseline 
survey of self-reported demographic factors, sexual and drug use 
behaviors, and potential cofactors of sexual and drug use behavior 
including attitudes, beliefs, knowledge, traits, and other psychosocial 
factors; follow-up surveys at 3-, 6-, 9-, and 12-month study visits 
which will assess experiences with PrEP, PrEP adherence, and behavioral 
and social factors; medication adherence data from CleverCap; 
participant use and voluntary self-reported adherence and HIV exposure 
risk-related data from the mChoice app; PrEP clinical care data from 
clinic electronic medical records; and urine studies assessing PrEP 
adherence. The information collected in Aim 1 will be used to evaluate 
the effectiveness of the mChoice intervention to improve PrEP adherence 
and persistence, and to increase understanding of PrEP experiences and 
factors that influence PrEP choices among MSM in clinical settings.
    Aim 2 of the study will enroll 30 YMSM who participated in Aim 1; 
15 from New York and 15 from Alabama. Participants will be recruited at 
Aim 1 study visits. Study staff will conduct in-depth interviews with 
Aim 2 participants exploring their experiences with PrEP, reasons for 
PrEP choices, and thoughts about the mChoice intervention. Data 
collected in Aim 2 will contribute to the evaluation of the mChoice 
intervention, implementation, and contribute to understanding factors 
that influence PrEP choices by MSM in clinical settings.
    Aim 3 of the study will include 20 health care providers (10 from 
New York and 10 from Alabama) involved in the direct delivery of PrEP 
services at participating clinical sites. Providers may include nurse 
practitioners, physicians, PrEP coordinators/navigators, medical 
assistants, and other cross-trained coordinators from the participating 
clinics. Providers will be recruited via flyers, emails to clinic 
staff, and referrals. Providers will receive education and training 
designed to improve knowledge of PrEP options and clinical 
recommendations and enhance provider communications with patients. Aim 
3 includes practice facilitation, an intervention that includes 
identification of a clinic champion who will engage other providers in 
embracing PrEP recommendations, as well as ongoing support from a 
practice coach who will offer tools, resources, hands-on guidance, and 
content expertise to assist the clinic team in developing strategies to 
improve clinical PrEP services. Aim 3 assessments include notes from 
practice facilitation coaching sessions; in-depth interviews of 
participating providers exploring their experiences with the 
intervention and thoughts about providing PrEP clinical services; and a 
clinic assessment completed by clinic staff every six months to 
describe the current implementation of PrEP services at their clinical 
site. These data will inform ongoing practice improvement in PrEP 
clinical services and increase understanding of provider experiences 
with providing PrEP clinical services.
    It is expected that half of screened persons will meet study 
eligibility. For all aims we anticipate that screening and completion 
of the locator form will each take five minutes. Study staff will 
assist Aim 1 participants with onboarding the CleverCap device and 
mChoice app, a process that will take 20 minutes. Aim 1 participants 
will complete the baseline survey once (anticipated 30 minutes 
completion time) and the follow-up survey four times (anticipated 
completion time 30 minutes each) over their 12-month participation 
period. Total study enrollment for Aim 1 is 400, over the 3-year data 
collection period the estimated annual enrollment is 134. Aims 2 and 3 
interviews will take 60 minutes to complete. For Aim 2, total study 
enrollment is 30, over the 3-year data collection period the estimated 
annual enrollment is 10. For Aim 3, total study enrollment is 20, over 
the 3-year data collection period the estimated annual enrollment is 
seven. Additionally, a single Aim 3 participant at each of the four 
participating clinic sites will complete a clinic assessment form every 
six months throughout the study period.
    There are no costs to the participants other than their time. The 
total number of burden hours is 1,323 across 36 months of data 
collection. The total estimated annualized burden hours are 441.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondent            Form name       respondents    responses per   response (in       (in hr)
                                                                    respondent          hr)
----------------------------------------------------------------------------------------------------------------
Aim 1 participants--YMSM;       Aim 1                        268               1            5/60              22
 General public, adults.         Participant
                                 Eligibility
                                 Screener.
Aim 1 participants--YMSM;       Aim 1                        134               1            5/60              12
 General public, adults.         Participant
                                 Locator Form.
Aim 1 participants--YMSM;       Aim 1 mChoice                134               1           20/60              45
 General public, adults.         Onboarding
                                 Guide.
Aim 1 participants--YMSM;       Aim 1                        134               1           30/60              67
 General public, adults.         Participant
                                 Baseline Survey.

[[Page 56836]]

 
Aim 1 participants--YMSM;       Aim 1                        134               4           30/60             268
 General public, adults.         Participant
                                 Follow-up
                                 Survey.
Aim 2 participants--YMSM;       Aim 2                         20               1            5/60               2
 General public, adults.         Participant
                                 Eligibility
                                 Screener.
Aim 2 participants--YMSM;       Aim 2                         10               1            5/60               1
 General public, adults.         Participant
                                 Locator Form.
Aim 2 participants--YMSM;       Aim 2                         10               1             1.0              10
 General public, adults.         Participant
                                 Interview Guide.
Aim 3 participants--providers;  Aim 3                         14               1            5/60               2
 General public, adults.         Participant
                                 Eligibility
                                 Screener.
Aim 3 participants--providers;  Aim 3                          7               1            5/60               1
 General public, adults.         Participant
                                 Locator Form.
Aim 3 participants--providers;  Aim 3                          7               1             1.0               7
 General public, adults.         Participant
                                 Interview Guide.
Aim 3 participant--clinic       Aim 3 Clinic                   4               2           30/60               4
 staff respondent, 1 per         Assessment.
 clinic site; General public,
 adults.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             441
----------------------------------------------------------------------------------------------------------------

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2023-17921 Filed 8-18-23; 8:45 am]
BILLING CODE 4163-18-P
```